MAUDE Adverse Event Report: ICU MEDICAL, INC. JELCO CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	328700
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: sample video was returned for review; leakage was observed, but the specific location and root cause could not be determined due to limited resolution.No device was returned for physical evaluation.Device history record review of the reported lot identified no manufacturing nonconformities.Therefore, the complaint cannot be confirmed as a manufacturing defect.If the device is returned, the complaint will be reopened for further investigation.
Event or Problem Description
It was reported that staff tried tightening the connection point, but it still leaked.The event occurred in the clinic operated by a health professional.No medical intervention was required, and no patient injuries occurred.They had to remove the iv and start a new one.

• Brand Name: JELCO CATHETER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ICU MEDICAL, INC.; 201 west queen st; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24474933
• Report Number: 3012307300-2026-01819
• Device Sequence Number: 10308615
• Product Code: FOZ
• UDI-Device Identifier: 10351688081940
• UDI-Public: (01)10351688081940(17)271105(10)6164475
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 328700
• Device Lot Number: 6164475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown